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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024070
Receipt No. R000027715
Scientific Title A study for evaluating the influence on a viability of lactic acid bacteria in intestinal tract due to the difference of form. A randomized, single-blind trial.
Date of disclosure of the study information 2016/09/16
Last modified on 2016/11/21

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Basic information
Public title A study for evaluating the influence on a viability of lactic acid bacteria in intestinal tract due to the difference of form. A randomized, single-blind trial.
Acronym A study for evaluating the influence on a viability of lactic acid bacteria in intestinal tract due to the difference of form.
Scientific Title A study for evaluating the influence on a viability of lactic acid bacteria in intestinal tract due to the difference of form. A randomized, single-blind trial.
Scientific Title:Acronym A study for evaluating the influence on a viability of lactic acid bacteria in intestinal tract due to the difference of form.
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the influence on a viability of lactic acid bacteria in intestinal tract due to different form for healthy volunteers
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of viable Lactobacillus brevis in the feces
Key secondary outcomes Number of subjects detected viable Lactobacillus brevis in the feces after ingestion of test food

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Lactic acid bacteria powder
Interventions/Control_2 Chocolate containing lactic acid bacteria
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Males and females from 20 to 64 years of age
(2) Subjects who have a daily bowel movement
(3) Subjects giving written informed consent
Key exclusion criteria (1) Individuals with a loose stool and/or a tendency for constipation
Individuals taking in common use
(2) Individuals taking antiflatulents and/or laxatives (including purgative drug) and/or health foods in common use, including food for specified health use
(3) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use
(4) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use, which influence intestinal regulation during the study period
(5) Individuals presenting known food allergy
(6) Individuals taking large amounts of alcohol on a daily basis
(7) Individuals who are suffered from a disease which needs treatment urgently or individuals with severe complications
(8) Individuals with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation
(9) Individuals who are under treatment or have a history of irritable bowel syndrome
(10) Individuals who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire
(11) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(12) Individuals who are under treatment or have a history of drug/alcohol dependence
(13) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics
(14) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Suzuki
Organization Shinagawa Season Terrace Health Care Clinic
Division name Medical examination and treatment management family chief director
Zip code
Address 1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL 03-3452-3381
Email satoru_suzuki@sempos.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Lotte Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 18 Day
Last follow-up date
2016 Year 10 Month 16 Day
Date of closure to data entry
2016 Year 10 Month 25 Day
Date trial data considered complete
2016 Year 11 Month 17 Day
Date analysis concluded
2016 Year 11 Month 18 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 15 Day
Last modified on
2016 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027715

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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